Influence of Vitamin D Supplementation on Serum BDNF Level and Cognitive Function in Schizophrenia
The Influence of Vitamin D Supplementation on Serum Brain Derived Neurotrophic Factor Level and Cognitive Function in Schizophrenia Treated With Atypical Antipsychotic
1 other identifier
interventional
40
0 countries
N/A
Brief Summary
The objective of the study is to evaluate the influence of vitamin D supplementation on Serum Brain Derived Neurotrophic Factor level and cognitive function in schizophrenia treated with atypical antipsychotic. Methods: The investigator will use randomized controlled trial design. 40 chronic schizophrenia patients with vitamin D insufficiency or deficiency treated with atypical antipsychotic, will be randomly assign (1:1 ratio) to receive either daily oral cholecalciferol 2000 IU or placebo for 8 weeks. Assessment of BDNF serum and cognitive function will be performed at baseline and after 8 weeks period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Apr 2020
Shorter than P25 for phase_3 schizophrenia
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 4, 2017
CompletedFirst Posted
Study publicly available on registry
September 15, 2017
CompletedStudy Start
First participant enrolled
April 15, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedApril 2, 2020
March 1, 2020
4 months
September 4, 2017
March 31, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Cognitive Function
cognitive function as measured with standard cognitive battery
At the end of week 8
Secondary Outcomes (1)
BDNF serum level
At the end of week 8
Study Arms (2)
Placebo
PLACEBO COMPARATOROral placebo daily for 8 weeks
Vitamin D
ACTIVE COMPARATORVitamin D Cholecalciferol 2000 IU oral daily for 8 weeks
Interventions
Eligibility Criteria
You may qualify if:
- Chronic schizophrenia
- Serum 25(OH)D level below 30 ng/ml
- Deficit in cognitive functions
You may not qualify if:
- Hypercalcemia
- Hepatic or renal failure
- Obese
- Metabolic syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
September 4, 2017
First Posted
September 15, 2017
Study Start
April 15, 2020
Primary Completion
August 1, 2020
Study Completion
December 1, 2020
Last Updated
April 2, 2020
Record last verified: 2020-03
Data Sharing
- IPD Sharing
- Will not share